薬理と治療

Abstract

Objective We carried out a drug use results survey（hereafter“this survey”）to confirm the safety and efficacy of travoprost ophthalmic solution（TRAVATANZ(R) 0.004％ ophthalmic solution） with long-term use in routine clinical practice. Methods This survey was carried out between July 14, 2008, and May 20, 2014 in patients with glaucoma or ocular hypertension recorded in a central registry. The standard follow-up period per patient（duration of use）was 24 months, and safety was investigated primarily by evaluating the development of adverse reactions and tabulating data on four priority survey items that were established in adverse. Efficacy was investigated by evaluating the response rate and reduction in intraocular pressure. Results The safety analysis for this survey included 4326 patients, and the efficacy analysis included 4142 patients. The incidence of adverse reactions was 33.1％（1432╱4326 patients）. Broken down by system organ class, the most common category was eye disorders, which accounted for 30.3％. Total of adverse reactions were reported 2601 cases. The main adverse reactions were hypertrichosis in 552 cases, blepharal pigmentation in 484, ocular hyperaemia in 416, iris hyperpigmentation in 347, conjunctival hyperaemia in 286, and punctate keratitis in 76. In 4045 of the 4142 patients included in the efficacy analysis（excluding 97 patients whose efficacy assessment was not recorded）, 75.2％（3040╱4045 patients）of patients were assessed as“effective”. Ocular pressure decreased significantly compared with baseline at all follow-up time-points from Month 1 to Month 24 after the start of administration in all the patients included in the efficacy analysis, patients newly treated with Travatanz(R) alone, and normal tension glaucoma patients（P＜0.0001 at all follow-up time-points）. Conclusions The results of this survey confirmed the safety and efficacy of long-term routine clinical use of Travatanz(R).